Cosmetic Microbiological Safety Issues; Public Meeting, 67461-67463 [2011-28238]
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<![CDATA[
67461
Federal Register / Vol. 76, No. 211 / Tuesday, November 1, 2011 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
respondents
21 CFR section
Total ........................................................................
1 There
Number of
responses per
respondent
Total annual
responses
Average burden
per response
........................
........................
........................
..............................
Total hours
95,083
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
Recordkeepers
21 CFR section
Number of
records per
recordkeeper
Total annual
records
Average burden per
recordkeeping
Total hours
558.6(c)(1) through (c)(4) ..........................................
558.6(e)(1) through (e)(4) ..........................................
112,500
5,000
10
75
1,125,000
375,000
.0167
.0167
18,788
6,263
Total ....................................................................
........................
........................
........................
..................................
25,051
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The estimate of the times required for
record preparation and maintenance is
based on Agency communication with
industry and Agency records and
experience.
Dated: October 27, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–28240 Filed 10–31–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0770]
Cosmetic Microbiological Safety
Issues; Public Meeting
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments and opening of a
docket.
ACTION:
The Food and Drug
Administration (FDA) is announcing a
public meeting entitled ‘‘Cosmetic
Microbiological Safety Issues.’’ The
purpose of the public meeting is to
provide stakeholders an opportunity to
present information regarding cosmetic
microbiological safety and to suggest
areas for the possible development of
FDA guidance documents. FDA is
seeking information regarding
microbiological testing of cosmetics;
types of preservative systems and how
to test their efficacy; the identity and
prevalence of microorganisms,
including antibiotic-resistant strains,
that pose specific health risks in
finished products; routes of exposure to
microorganisms and the corresponding
infective doses; product and packaging
srobinson on DSK4SPTVN1PROD with NOTICES
SUMMARY:
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Jkt 226001
characteristics that affect microbial
growth and risk of infection; particular
subpopulations that may be at greater
risk of infection when using different
cosmetic products; the occurrence of
adverse events associated with
microbial contamination of cosmetics;
and any other issues relevant to the
microbiological safety of cosmetics.
DATES: Submit either electronic or
written comments to FDA’s Division of
Dockets Management by January 30,
2012. See also ‘‘How to Participate in
the Meeting’’ in the SUPPLEMENTARY
INFORMATION section of this document
for important meeting registration
deadlines.
ADDRESSES: See Table 1 of this
document for meeting location and
other information regarding registration
for this meeting.
FOR FURTHER INFORMATION CONTACT: For
questions about registering for the
meeting, to register orally, or to submit
a notice of participation by mail, fax, or
email: Courtney Treece, Planning
Professionals, Ltd., 1210 W. McDermott,
suite 111, Allen, TX 75013, (704) 258–
4983. Fax: (469) 854–6992,
ctreece@planningprofessionals.com.
For questions about the meeting, to
request an opportunity to make public
comments, to submit the full text,
comprehensive outline, or summary of
an oral presentation, or to request
special accommodations due to a
disability: Juanita Yates, Center for Food
Safety and Applied Nutrition, Food and
Drug Administration, (240) 402–1731,
Juanita.Yates@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA regulates cosmetics under the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 301 et seq.)
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
and, for products marketed on a retail
basis to consumers, under the Fair
Packaging and Labeling Act (FPLA) (15
U.S.C. 1451 et seq.). The law requires
that cosmetics be neither adulterated
under section 601 of the FD&C Act (21
U.S.C. 361) nor misbranded under
section 602 of the FD&C Act (21 U.S.C.
362). That is, they must be safe for
consumers under labeled or customary
conditions of use and they must be
properly labeled. FDA has issued
regulations addressing certain aspects of
cosmetic safety and labeling (see 21 CFR
parts 700, 701, and 740). FDA has also
issued guidance regarding certain
aspects of cosmetic safety and labeling,
including the ‘‘Good Manufacturing
Practice (GMP) Guidelines/Inspection
Checklist’’ (available at https://
www.fda.gov/Cosmetics/Guidance
ComplianceRegulatoryInformation/
GoodManufacturingPracticeGMP
GuidelinesInspectionChecklist/
default.htm), the ‘‘Cosmetic Labeling
Manual’’ (available at https://
www.fda.gov/Cosmetics/Cosmetic
LabelingLabelClaims/CosmeticLabeling
Manual/default.htm), and other
cosmetic guidance documents (available
at https://www.fda.gov/Cosmetics/
GuidanceComplianceRegulatory
Information/GuidanceDocuments/
default.htm).
FDA has not yet issued specific
guidance regarding cosmetic
microbiological safety. FDA has
presented its preferred laboratory
procedures for microbiological analyses
of foods and cosmetics in its
Bacteriological Analytical Manual
(BAM). Chapter 23 of the BAM concerns
microbiological methods for cosmetics
(available at https://www.fda.gov/Food/
ScienceResearch/LaboratoryMethods/
BacteriologicalAnalyticalManualBAM/
ucm073598.htm).
E:\FR\FM\01NON1.SGM
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67462
Federal Register / Vol. 76, No. 211 / Tuesday, November 1, 2011 / Notices
Microbial contamination of cosmetic
products is of concern to FDA because
of the potential for serious adverse
events. Cosmetics intended to be used
in the area of the eye are of particular
concern. Eye-area cosmetics that contain
pathogenic microorganisms have the
potential to cause serious eye infections
which can, in some cases, result in
partial or total loss of vision. In
addition, contaminated alcohol-free
mouthwash has caused outbreaks of
serious bacterial illness among
hospitalized patients. Other microbially
contaminated cosmetic product types,
such as skin lotions, also have the
potential to cause significant irritation
or infection.
A variety of factors can affect the
microbiological safety of cosmetic
products. Microbial contaminants can
be introduced during manufacturing,
packaging, or repacking. Microbial
growth can be supported by certain
product characteristics, such as high
water content. Microorganisms can also
be introduced by consumers during use.
Certain forms of cosmetic product
packaging may serve to limit or prevent
the introduction of microorganisms.
Preservative systems are intended to
protect consumers from microorganisms
introduced during manufacturing and
while using a product, but inadequate
preservative systems may fail to do so.
Some microorganisms are known to be
pathogenic, that is, they are capable of
causing injury or illness, while others
are not. Certain microorganisms may
pose little risk to most consumers, but
may pose significant risks to vulnerable
consumers, such as those with
compromised immune systems.
FDA believes that guidance on factors
and practices to promote the
microbiological safety of cosmetics
would benefit consumers and industry.
FDA is contemplating developing such
guidance and is seeking information
about microbiological safety of
cosmetics. This public meeting is
intended to provide stakeholders the
opportunity to present information
regarding microbiological testing of
cosmetics; types of preservative systems
and how to test their efficacy; the
identity and prevalence of
microorganisms, including antibioticresistant strains, that pose specific
health risks in finished products; routes
of exposure to microorganisms and the
corresponding infective doses; product
and packaging characteristics that affect
microbial growth and risk of infection;
particular subpopulations that may be at
greater risk of infection when using
different cosmetic products; the
occurrence of adverse events associated
with microbial contamination of
cosmetics; and any other issues relevant
to the microbiological safety of
cosmetics.
II. Purpose and Format of the Meeting
If you wish to present at the meeting
scheduled for November 30, 2011,
please register at https://www.fda.gov/
Food/NewsEvents/WorkshopsMeetings
Conferences/default.htm by November
10, 2011. If you wish to attend the
meeting but not give a presentation,
please register at https://www.fda.gov/
Food/NewsEvents/WorkshopsMeetings
Conferences/default.htm by November
21, 2011. FDA is holding the public
meeting on cosmetic microbiological
safety issues to receive input from the
public to support the development of
guidance. The meeting format will
include introductory presentations by
FDA, followed by the opportunity for
stakeholders to make presentations or
offer remarks. Listening to our
stakeholders is the primary purpose of
this meeting. In order to meet this goal,
FDA will provide multiple
opportunities for individuals to actively
express their views by making
presentations at the meeting and
submitting written comments to FDA’s
Division of Dockets Management within
60 days of this meeting.
III. How To Participate in the Meeting
Stakeholders will have an opportunity
to provide oral comments. Due to
limited space and time, FDA encourages
all persons who wish to attend the
meeting to register in advance.
Interested persons and organizations
who desire an opportunity to make an
oral presentation during the time
allotted for public comment at the
meeting, are encouraged to register in
advance and to provide the specific
topic or issue to be addressed and the
approximate desired length of their
presentation. Depending on the number
of requests for such oral presentations,
there may be a need to limit the time of
each oral presentation (e.g., 3 minutes
each). If time permits, individuals or
organizations that did not register in
advance may be granted the opportunity
for such an oral presentation. FDA
would like to maximize the number of
stakeholders who make a presentation at
the meeting and will do our best to
accommodate all persons who wish to
make a presentation or express their
views at the meeting. FDA encourages
persons and groups who have similar
interests to consolidate their
information for presentation through a
single representative. After reviewing
the presentation requests, FDA will
notify each participant before the
meeting of the amount of time available
and the approximate time their
presentation is scheduled to begin.
Stakeholders will also have an
opportunity to submit electronic or
written comments to the docket
following the meeting, but no later than
January 30, 2012.
There is no fee to register for the
public meeting and registration will be
on a first-come, first-served basis. Early
registration is recommended because
seating is limited.
Table 1 of this document provides
information on participating in the
meeting and on submitting comments to
the docket.
TABLE 1—INFORMATION ON PARTICIPATION IN THE MEETING AND ON SUBMITTING COMMENTS
Electronic address
Address
(non-electronic)
Individuals who wish to participate
in person are asked to pre-register at https://www.fda.gov/Food/
NewsEvents/WorkshopsMeetings
Conferences/default.htm.
https://www.fda.gov/Food/News
Events/WorkshopsMeetingsConferences/default.htm.
L’Enfant Plaza Hotel,
480 L’Enfant Plaza
Southwest, Washington, DC, 20024–
2253.
FDA encourages the
use of electronic registration if possible.
Juanita Yates, e-mail: Juanita.Yates
@fda.hhs.gov.
Juanita Yates, 240–
402–1731.
Date
srobinson on DSK4SPTVN1PROD with NOTICES
Date of Public Meeting ..
November 30, 2011,
from 9 a.m. to 5:30
p.m. EST.
Advance Registration ....
Register by November
21, 2011.
Request special accommodations due to disability.
Register by November
21, 2011.
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Other information
Registration begins at 8 a.m.
Registration to attend the meeting will also be
accepted onsite on the day of the meeting,
as space permits. Registration information
may be posted without change to https://
www.regulations.gov including any personal
information provided.
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Federal Register / Vol. 76, No. 211 / Tuesday, November 1, 2011 / Notices
67463
TABLE 1—INFORMATION ON PARTICIPATION IN THE MEETING AND ON SUBMITTING COMMENTS—Continued
Date
Electronic address
Address
(non-electronic)
Other information
Make a request for oral
presentation.
Submit a request by
November 10, 2011.
https://www.fda.gov/Food/News
Events/WorkshopsMeetingsConferences/default.htm.
......................................
Provide a brief description of the oral presentation and any written material for the
presentation.
By November 21, 2011
https://www.fda.gov/Food/
NewsEvents/WorkshopsMeetings
Conferences/default.htm.
......................................
Submit electronic or
written comments.
Submit comments by
January 30, 2012.
Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Fax: 301–827–6870,
Mail/Hand delivery/
Courier (for paper,
disk, or CD–ROM
submissions): Division of Dockets Management (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, rm.
1061, Rockville, MD
20852.
Requests made on the day of the meeting to
make an oral presentation will be granted as
time permits. Information on requests to
make an oral presentation may be posted
without change to https://www.regulations.gov,
including any personal information provided.
Written material associated with an oral presentation should be submitted in Microsoft
PowerPoint, Microsoft Word, or Adobe Portable Document Format (PDF) and may be
posted
without
change
to
https://
www.regulations.gov, including any personal
information provided.
All comments must include the Agency name
and the docket number corresponding to the
Cosmetic Microbiological Safety Issues; Public Meeting. All received comments may be
posted
without
change
to
https://
www.regulations.gov, including any personal
information provided. FDA encourages the
submission of electronic comments by using
the Federal eRulemaking Portal. For additional information on submitting comments,
see the ‘‘Comments’’ heading of the SUPPLEMENTARY INFORMATION section of
this document.
IV. Comments
Regardless of attendance at the public
meeting, interested persons may submit
to the Division of Dockets management
(see Table 1 of this document) either
electronic or written comments for
consideration at or after the meeting in
addition to, or in place of, a request for
an opportunity to make an oral
presentation. It is only necessary to send
one set of comments. It is no longer
necessary to send two copies of mailed
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be viewed in the
Division of Dockets Management at the
address provided in Table 1 of this
document between 9 a.m. and 4 p.m.,
Monday through Friday.
srobinson on DSK4SPTVN1PROD with NOTICES
V. References
We have placed hard copies of the
following references on display in the
Division of Dockets Management (see
ADDRESSES). You may view them
between 9 a.m. and 4 p.m., Monday
through Friday. (FDA has verified the
Web site addresses, but FDA is not
responsible for any subsequent changes
to Web sites after this document
publishes in the Federal Register.)
1. FDA, ‘‘Good Manufacturing
Practice (GMP) Guidelines/Inspection
Checklist,’’ available at https://
www.fda.gov/Cosmetics/Guidance
ComplianceRegulatoryInformation/
GoodManufacturingPracticeGMP
GuidelinesInspectionChecklist/
default.htm.
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17:04 Oct 31, 2011
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2. FDA, ‘‘Cosmetic Labeling Manual,’’
available at https://www.fda.gov/
Cosmetics/CosmeticLabelingLabel
Claims/CosmeticLabelingManual/
default.htm.
3. FDA, ‘‘Guidance Documents,’’
available at https://www.fda.gov/
Cosmetics/GuidanceCompliance
RegulatoryInformation/Guidance
Documents/default.htm.
4. FDA, Bacteriological Analytical
Manual, chapter 23, ‘‘Microbiological
Methods for Cosmetics,’’ available at
https://www.fda.gov/Food/Science
Research/LaboratoryMethods/
BacteriologicalAnalyticalManualBAM/
ucm073598.htm.
VI. Transcripts
Please be advised that as soon as a
transcript is available, it will be
accessible at https://www.regulations.gov
and at FDA’s Web site under
‘‘Cosmetics.’’ It may also be viewed at
the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. A transcript
will also be available in either hardcopy
or on CD–ROM, after the submission of
a Freedom of Information request.
Written requests are to be sent to
Division of Freedom of Information
(ELEM–1029), Food and Drug
Administration, 12420 Parklawn Dr.,
Element Bldg., Rockville, MD 20857.
Dated: October 26, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–28238 Filed 10–31–11; 8:45 am]
BILLING CODE 4160–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0754]
Pediatric Medical Devices; Public
Workshop; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
The Food and Drug Administration
(FDA) is announcing a public workshop
entitled ‘‘Using Scientific Research Data
to Support Pediatric Medical Device
Claims: A Public Dialogue.’’ The
purpose of the public workshop is to
receive public comment on the use of
scientific research data, including
published scientific literature, to
support and establish pediatric
indications for medical devices.
The topics to be discussed are: The
ways scientific research data can be
used to support pediatric effectiveness
claims for medical devices and pediatric
device approvals or clearance; the
scientific and regulatory limitations and
issues of using existing scientific
research data to support pediatric
effectiveness claims and pediatric
indication approvals for medical
devices; and methods to overcome the
pitfalls and data gaps, including
statistical approaches and modeling.
Date and Time: The public workshop
will be held on December 5, 2011, from
8:30 a.m. to 5 p.m. EST.
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]]>Agencies
[Federal Register Volume 76, Number 211 (Tuesday, November 1, 2011)]
[Notices]
[Pages 67461-67463]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-28238]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0770]
Cosmetic Microbiological Safety Issues; Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments and opening of a
docket.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting entitled ``Cosmetic Microbiological Safety Issues.'' The
purpose of the public meeting is to provide stakeholders an opportunity
to present information regarding cosmetic microbiological safety and to
suggest areas for the possible development of FDA guidance documents.
FDA is seeking information regarding microbiological testing of
cosmetics; types of preservative systems and how to test their
efficacy; the identity and prevalence of microorganisms, including
antibiotic-resistant strains, that pose specific health risks in
finished products; routes of exposure to microorganisms and the
corresponding infective doses; product and packaging characteristics
that affect microbial growth and risk of infection; particular
subpopulations that may be at greater risk of infection when using
different cosmetic products; the occurrence of adverse events
associated with microbial contamination of cosmetics; and any other
issues relevant to the microbiological safety of cosmetics.
DATES: Submit either electronic or written comments to FDA's Division
of Dockets Management by January 30, 2012. See also ``How to
Participate in the Meeting'' in the SUPPLEMENTARY INFORMATION section
of this document for important meeting registration deadlines.
ADDRESSES: See Table 1 of this document for meeting location and other
information regarding registration for this meeting.
FOR FURTHER INFORMATION CONTACT: For questions about registering for
the meeting, to register orally, or to submit a notice of participation
by mail, fax, or email: Courtney Treece, Planning Professionals, Ltd.,
1210 W. McDermott, suite 111, Allen, TX 75013, (704) 258-4983. Fax:
(469) 854-6992, ctreece@planningprofessionals.com.
For questions about the meeting, to request an opportunity to make
public comments, to submit the full text, comprehensive outline, or
summary of an oral presentation, or to request special accommodations
due to a disability: Juanita Yates, Center for Food Safety and Applied
Nutrition, Food and Drug Administration, (240) 402-1731,
Juanita.Yates@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA regulates cosmetics under the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 301 et seq.) and, for products marketed
on a retail basis to consumers, under the Fair Packaging and Labeling
Act (FPLA) (15 U.S.C. 1451 et seq.). The law requires that cosmetics be
neither adulterated under section 601 of the FD&C Act (21 U.S.C. 361)
nor misbranded under section 602 of the FD&C Act (21 U.S.C. 362). That
is, they must be safe for consumers under labeled or customary
conditions of use and they must be properly labeled. FDA has issued
regulations addressing certain aspects of cosmetic safety and labeling
(see 21 CFR parts 700, 701, and 740). FDA has also issued guidance
regarding certain aspects of cosmetic safety and labeling, including
the ``Good Manufacturing Practice (GMP) Guidelines/Inspection
Checklist'' (available at https://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/GoodManufacturingPracticeGMPGuidelinesInspectionChecklist/default.htm),
the ``Cosmetic Labeling Manual'' (available at https://www.fda.gov/Cosmetics/CosmeticLabelingLabelClaims/CosmeticLabelingManual/default.htm), and other cosmetic guidance documents (available at
https://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/default.htm).
FDA has not yet issued specific guidance regarding cosmetic
microbiological safety. FDA has presented its preferred laboratory
procedures for microbiological analyses of foods and cosmetics in its
Bacteriological Analytical Manual (BAM). Chapter 23 of the BAM concerns
microbiological methods for cosmetics (available at https://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/ucm073598.htm).
[[Page 67462]]
Microbial contamination of cosmetic products is of concern to FDA
because of the potential for serious adverse events. Cosmetics intended
to be used in the area of the eye are of particular concern. Eye-area
cosmetics that contain pathogenic microorganisms have the potential to
cause serious eye infections which can, in some cases, result in
partial or total loss of vision. In addition, contaminated alcohol-free
mouthwash has caused outbreaks of serious bacterial illness among
hospitalized patients. Other microbially contaminated cosmetic product
types, such as skin lotions, also have the potential to cause
significant irritation or infection.
A variety of factors can affect the microbiological safety of
cosmetic products. Microbial contaminants can be introduced during
manufacturing, packaging, or repacking. Microbial growth can be
supported by certain product characteristics, such as high water
content. Microorganisms can also be introduced by consumers during use.
Certain forms of cosmetic product packaging may serve to limit or
prevent the introduction of microorganisms. Preservative systems are
intended to protect consumers from microorganisms introduced during
manufacturing and while using a product, but inadequate preservative
systems may fail to do so. Some microorganisms are known to be
pathogenic, that is, they are capable of causing injury or illness,
while others are not. Certain microorganisms may pose little risk to
most consumers, but may pose significant risks to vulnerable consumers,
such as those with compromised immune systems.
FDA believes that guidance on factors and practices to promote the
microbiological safety of cosmetics would benefit consumers and
industry. FDA is contemplating developing such guidance and is seeking
information about microbiological safety of cosmetics. This public
meeting is intended to provide stakeholders the opportunity to present
information regarding microbiological testing of cosmetics; types of
preservative systems and how to test their efficacy; the identity and
prevalence of microorganisms, including antibiotic-resistant strains,
that pose specific health risks in finished products; routes of
exposure to microorganisms and the corresponding infective doses;
product and packaging characteristics that affect microbial growth and
risk of infection; particular subpopulations that may be at greater
risk of infection when using different cosmetic products; the
occurrence of adverse events associated with microbial contamination of
cosmetics; and any other issues relevant to the microbiological safety
of cosmetics.
II. Purpose and Format of the Meeting
If you wish to present at the meeting scheduled for November 30,
2011, please register at https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm by November 10, 2011. If you
wish to attend the meeting but not give a presentation, please register
at https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm by November 21, 2011. FDA is holding the public meeting on
cosmetic microbiological safety issues to receive input from the public
to support the development of guidance. The meeting format will include
introductory presentations by FDA, followed by the opportunity for
stakeholders to make presentations or offer remarks. Listening to our
stakeholders is the primary purpose of this meeting. In order to meet
this goal, FDA will provide multiple opportunities for individuals to
actively express their views by making presentations at the meeting and
submitting written comments to FDA's Division of Dockets Management
within 60 days of this meeting.
III. How To Participate in the Meeting
Stakeholders will have an opportunity to provide oral comments. Due
to limited space and time, FDA encourages all persons who wish to
attend the meeting to register in advance. Interested persons and
organizations who desire an opportunity to make an oral presentation
during the time allotted for public comment at the meeting, are
encouraged to register in advance and to provide the specific topic or
issue to be addressed and the approximate desired length of their
presentation. Depending on the number of requests for such oral
presentations, there may be a need to limit the time of each oral
presentation (e.g., 3 minutes each). If time permits, individuals or
organizations that did not register in advance may be granted the
opportunity for such an oral presentation. FDA would like to maximize
the number of stakeholders who make a presentation at the meeting and
will do our best to accommodate all persons who wish to make a
presentation or express their views at the meeting. FDA encourages
persons and groups who have similar interests to consolidate their
information for presentation through a single representative. After
reviewing the presentation requests, FDA will notify each participant
before the meeting of the amount of time available and the approximate
time their presentation is scheduled to begin. Stakeholders will also
have an opportunity to submit electronic or written comments to the
docket following the meeting, but no later than January 30, 2012.
There is no fee to register for the public meeting and registration
will be on a first-come, first-served basis. Early registration is
recommended because seating is limited.
Table 1 of this document provides information on participating in
the meeting and on submitting comments to the docket.
Table 1--Information on Participation in the Meeting and on Submitting Comments
----------------------------------------------------------------------------------------------------------------
Electronic Address (non-
Date address electronic) Other information
----------------------------------------------------------------------------------------------------------------
Date of Public Meeting......... November 30, Individuals who L'Enfant Plaza Registration begins at
2011, from 9 wish to Hotel, 480 8 a.m.
a.m. to 5:30 participate in L'Enfant Plaza
p.m. EST. person are asked Southwest,
to pre-register Washington, DC,
at https:// 20024-2253.
www.fda.gov/Food/
NewsEvents/
WorkshopsMeeting
sConferences/
default.htm.
Advance Registration........... Register by https:// FDA encourages Registration to attend
November 21, www.fda.gov/Food/ the use of the meeting will also
2011. NewsEvents/ electronic be accepted onsite on
WorkshopsMeeting registration if the day of the
sConferences/ possible. meeting, as space
default.htm. permits. Registration
information may be
posted without change
to https://www.regulations.gov
including any
personal information
provided.
Request special accommodations Register by Juanita Yates, e- Juanita Yates, ......................
due to disability. November 21, mail: 240-402-1731.
2011. Juanita.Yates@fda.hhs.gov.
[[Page 67463]]
Make a request for oral Submit a request https:// ................. Requests made on the
presentation. by November 10, www.fda.gov/Food/ day of the meeting to
2011. NewsEvents/ make an oral
WorkshopsMeeting presentation will be
sConferences/ granted as time
default.htm. permits. Information
on requests to make
an oral presentation
may be posted without
change to https://www.regulations.gov,
including any
personal information
provided.
Provide a brief description of By November 21, https:// ................. Written material
the oral presentation and any 2011. www.fda.gov/Food/ associated with an
written material for the NewsEvents/ oral presentation
presentation. WorkshopsMeeting should be submitted
sConferences/ in Microsoft
default.htm. PowerPoint, Microsoft
Word, or Adobe
Portable Document
Format (PDF) and may
be posted without
change to https://www.regulations.gov,
including any
personal information
provided.
Submit electronic or written Submit comments Federal Fax: 301-827- All comments must
comments. by January 30, eRulemaking 6870, Mail/Hand include the Agency
2012. Portal: https:// delivery/Courier name and the docket
www.regulations. (for paper, number corresponding
gov. Follow the disk, or CD-ROM to the Cosmetic
instructions for submissions): Microbiological
submitting Division of Safety Issues; Public
comments. Dockets Meeting. All received
Management (HFA- comments may be
305), Food and posted without change
Drug to https://
Administration, www.regulations.gov,
5630 Fishers including any
Lane, rm. 1061, personal information
Rockville, MD provided. FDA
20852. encourages the
submission of
electronic comments
by using the Federal
eRulemaking Portal.
For additional
information on
submitting comments,
see the ``Comments''
heading of the
SUPPLEMENTARY
INFORMATION section
of this document.
----------------------------------------------------------------------------------------------------------------
IV. Comments
Regardless of attendance at the public meeting, interested persons
may submit to the Division of Dockets management (see Table 1 of this
document) either electronic or written comments for consideration at or
after the meeting in addition to, or in place of, a request for an
opportunity to make an oral presentation. It is only necessary to send
one set of comments. It is no longer necessary to send two copies of
mailed comments. Identify comments with the docket number found in
brackets in the heading of this document. Received comments may be
viewed in the Division of Dockets Management at the address provided in
Table 1 of this document between 9 a.m. and 4 p.m., Monday through
Friday.
V. References
We have placed hard copies of the following references on display
in the Division of Dockets Management (see ADDRESSES). You may view
them between 9 a.m. and 4 p.m., Monday through Friday. (FDA has
verified the Web site addresses, but FDA is not responsible for any
subsequent changes to Web sites after this document publishes in the
Federal Register.)
1. FDA, ``Good Manufacturing Practice (GMP) Guidelines/Inspection
Checklist,'' available at https://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/GoodManufacturingPracticeGMPGuidelinesInspectionChecklist/default.htm.
2. FDA, ``Cosmetic Labeling Manual,'' available at https://www.fda.gov/Cosmetics/CosmeticLabelingLabelClaims/CosmeticLabelingManual/default.htm.
3. FDA, ``Guidance Documents,'' available at https://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/default.htm.
4. FDA, Bacteriological Analytical Manual, chapter 23,
``Microbiological Methods for Cosmetics,'' available at https://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/ucm073598.htm.
VI. Transcripts
Please be advised that as soon as a transcript is available, it
will be accessible at https://www.regulations.gov and at FDA's Web site
under ``Cosmetics.'' It may also be viewed at the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. A transcript will also be available in
either hardcopy or on CD-ROM, after the submission of a Freedom of
Information request. Written requests are to be sent to Division of
Freedom of Information (ELEM-1029), Food and Drug Administration, 12420
Parklawn Dr., Element Bldg., Rockville, MD 20857.
Dated: October 26, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-28238 Filed 10-31-11; 8:45 am]
BILLING CODE 4160-01-P
